Pharmaceutical Technology, Sep 2, 2013 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Sep 2, 2013
Cover Story
Quality by Design in APIs
By Patricia Van Arnum
The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs
Featured Content
The Importance of Characterization in Biosimilars Development
By Adeline Siew, PhD
Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.
Peer-Reviewed Research
Overcoming Limitations of Vaporized Hydrogen Peroxide
By James P. Agalloco , James E. Akers
Vaporous hydrogen peroxide, used for sterilization and decontamination, is highly potent but presents implementation challenges.
Effective and Efficient Weighing of Potent Compounds
By George Hartford , Patty Cheung , Karen Whitaker , Roy Helmy, PhD , Joanne Ratcliff, PhD
The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
API Synthesis & Manufacturing
Advancing Chiral Chemistry in Pharmaceutical Synthesis
By Patricia Van Arnum
Developments involve stereoretentive cross-coupling, enantioselective alcohol silylation, strategies for amplifying signals in circular dichroism spectroscopy, and a synthetic route for the natural product ingenol.
Regulation & Compliance
FDA Works to Secure Drug Supply Chain
By Jill Wechsler
New FDA supply chain policies aim to strengthen inspection and oversight processes.
EU Raises API Standards: A Curse in Disguise?
By Sean Milmo
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
Statistical Solutions
The Basics of Measurement Uncertainty in Pharma Analysis
By Chris Burgess
How good is a reportable value?
Insider Solutions
The Elements of Training
By Susan J. Schniepp
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Troubleshooting
Best Practices for Restricted Access Barrier Systems
By Joerg Zimmermann
Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.
Outsourcing
Outsourcing Partnerships for CMC Development
By Jim Miller
Are strategic partnerships in clinical research a model for CMC services?
Global Feature
Report from Brazil
By Hellen Berger
Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.
Ask the Expert
Multivariate Approaches for Powder Characterization
John Yin, an applications specialist with Freeman Technology, discusses the importance of powder-characterization techniques for optimizing pharmaceutical product development and manufacturing processes.
Guest Editorial
The Importance of Continued Investment in R&D
By Mark Howard
There has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.
Connecting People, Science, and Regulation
By Richard Johnson
PDA/FDA regulatory conference promotes a commitment to quality.
Product Spotlight
Omega Design Corporation Introduces LabelSync 450
Omega Design Corporation offers the LabelSync 450 Vision Module, designed to capture and sync a bottle?s unique serialized label with its individual line code.
Bosspak VTC 100 Tablet and Capsule Counter
The Bosspak VTC 100 electronic tablet and capsule counter from Romaco?s is designed to fill pharmaceutical solids or food supplements into bottles at high speed.
MF40 Automated Punch and Die Polishing Machine
I Holland has introduced the next generation to its range of MF polishers, the MF40 automated punch, and die polishing machine.
XstalBio Introduces CentuRecon
CentuRecon enables dry formulations of therapeutic proteins to quickly be prepared for injection at high concentration.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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